East Rutherford, NJ – Cambrex Corporation (NYSE: CBM, “Cambrex”) announced that the US Food and Drug Administration (FDA) completed an inspection of Cambrex’s active pharmaceutical ingredient (API) manufacturing facility in Charles City, Iowa. The Pre-Approval Inspection (PAI), conducted in February 2014 for a new API, found the site to be compliant with the principles and guidelines of Good Manufacturing Practice (GMP) and there were no Form 483 observations issued.
“Once again, we are extremely happy with the result of this FDA inspection. Our customers continue to be impressed with our commitment to quality and our exceptional regulatory compliance track record,” remarked Joe Nettleton, VP of Operations and Site Director for Cambrex Charles City.
The entire facility and the quality systems used for the manufacture and release of APIs, drug product intermediates, and food grade products were subject to a detailed compliance inspection by the US FDA. This inspection follows successful PAI and GMP inspections by the US FDA at Cambrex Charles City in July 2013 and February 2012, neither of which resulted in any Form 483 observations, and the KFDA (Korea) in January 2012 and the MHRA (UK) in October 2011.